Evaluating real-world COVID-19 vaccine effectiveness using a test-negative case-control design

Matthew W Reynolds, Alex Secora, Alice Joules, Lisa Albert, Emma Brinkley, Tom Kwon, Christina Mack, Stephen Toovey, Nancy A Dreyer, Matthew W Reynolds, Alex Secora, Alice Joules, Lisa Albert, Emma Brinkley, Tom Kwon, Christina Mack, Stephen Toovey, Nancy A Dreyer

Abstract

Aim: It is important to assess if clinical trial efficacy translates into real-world effectiveness for COVID-19 vaccines. Materials & methods: We conducted a modified test-negative design (TND) to evaluate the real-world effectiveness of three COVID-19 vaccines. We defined cases in two ways: self-reported COVID-19-positive tests, and self-reported positive tests with ≥1 moderate/severe COVID-19 symptom. Results: Any vaccination was associated with a 95% reduction in subsequently reporting a positive COVID-19 test, and a 71% reduction in reporting a positive test and ≥1 moderate/severe symptom. Conclusion: We observed high effectiveness across all three marketed vaccines, both for self-reported positive COVID-19 tests and moderate/severe COVID-19 symptoms. This innovative TND approach can be implemented in future COVID-19 vaccine and treatment real-world effectiveness studies. Clinicaltrials.gov identifier: NCT04368065.

Keywords: COVID-19; SARS-CoV-2; patient-reported outcomes; person-generated health data; symptoms; test-negative design; vaccines.

Figures

Figure 1.. Vaccination status determination at time…
Figure 1.. Vaccination status determination at time of COVID-19 testing for single-dose and two-dose vaccines.
Figure 2.. Vaccine effectiveness of preventing cases…
Figure 2.. Vaccine effectiveness of preventing cases of COVID-19 among those with at least one vaccination versus unvaccinated, overall and by manufacturer (primary analysis based on COVID-19 test results).
Figure 3.. Vaccine effectiveness of preventing cases…
Figure 3.. Vaccine effectiveness of preventing cases of COVID-19 among those with at least one vaccination versus unvaccinated, overall and by manufacturer (secondary analysis based on test results and requiring at least one moderate to severe symptom).

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Source: PubMed

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